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Dutoprol

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Dutoprol

Indications
Dosage
How Supplied

INDICATIONS

DUTOPROL (metoprolol succinate and hydrochlorothiazide) is a combination tablet of metoprolol succinate, a beta adrenoceptor blocking agent and hydrochlorothiazide, a diuretic. DUTOPROL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol and hydrochlorothiazide.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

DUTOPROL may be administered with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended starting dose of DUTOPROL (metoprolol succinate extended release and hydrochlorothiazide) is 25 mg/12.5 mg taken orally once daily with or without food. Depending on the blood pressure response, the dose may be titrated at intervals of 2 weeks to a maximum recommended dose of 200 mg/25 mg (two DUTOPROL 100 mg/12.5 mg tablets) once daily [see Clinical Studies].

For specific advice on blood pressure goals, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Use With And Switching From Other Anti-Hypertensive Drugs

DUTOPROL may be administered with other antihypertensive drugs. Patients titrated to the individual components (metoprolol succinate and hydrochlorothiazide) may instead receive the corresponding dose of DUTOPROL.

A patient whose blood pressure is inadequately controlled by metoprolol succinate alone or hydrochlorothiazide alone may be switched to DUTOPROL.

HOW SUPPLIED

Dosage Forms And Strengths

25/12.5 mg tablets: Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side.

50/12.5 mg tablets: Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side.

100/12.5 mg tablets: Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side.

Storage And Handling

DUTOPROL is supplied as circular, biconvex, film-coated tablets engraved on one side.

Metoprolol/ Hydrochlorothiazide Engraving Scored NDC 24987-xxx-xx
Bottle/30
25/12.5 mg A No 087-30
IH
50/12.5 mg A No 095-30
IK
100/12.5 mg A Yes 097-30
IL

Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). (See USP Controlled Room Temperature.)

Last reviewed on RxList: 11/3/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

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